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SMC ID Date Medicine Submission Type Indication
SMC2888 08/12/2025 trastuzumab deruxtecan (Enhertu) Non submission

Monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment

SMC2854 11/08/2025 trastuzumab deruxtecan (Enhertu) Non submission

For the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

SMC2706 12/08/2024 trastuzumab deruxtecan (Enhertu) Non submission

As monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

SMC2693 08/07/2024 trastuzumab deruxtecan (Enhertu) Non submission

As monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

SMC2608 11/12/2023 trastuzumab deruxtecan (Enhertu) Full

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

SMC2545 10/04/2023 trastuzumab deruxtecan (Enhertu) Full

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens.

SMC2388 17/01/2022 trastuzumab deruxtecan (Enhertu) Full

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (HER2+) breast cancer who have received two or more prior anti-HER2-based regimens.

No medicines have been found.